NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Easy on the ulcer Scotty. Lets recap last weeks antidote against panic.

As it seems to be the case, that each morning opens with the prosecution delivering the same speech for a guilty verdict, perhaps the defense should start repeating its case indefinitely also.

TLD + Publication comes simultaneously

Ever since data lock October 5th. its been the end goal for NWBO to publish announcement and publication at the same time.

The data lock PR stated:

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

PR May 12th.

In a PR NWBO restated, what was said at data lock.

The process outlined in the Company’s October 5, 2020 announcement relating to the Phase III trial of DCVax-L is continuing to move forward. The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.

At the Annual Shareholder Meeting May 18th 2021 Linda Powers reiterated:

As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock.

10Q Quarterly Report filing January 2021

As explained in our prior announcements, following Data Lock the independent statisticians conduct analyses of the raw data and Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for scientific publication and for public announcement. During this process, any questions or comments from the experts will be addressed as part of the preparation of the results for publication and public reporting

In annual Report 10K March 31st. 2021

On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes

In quarterly report 10Q May 17th

On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes

In 10Q from August 16th 2021

On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and independent experts, in preparation for publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes.

Conclusion:
Beyond all doubt, NWBO has from beginning of data lock till date, specifically stated, that TLD and a scientific journal are their endgame.

How long time has NWBO been working at the scientific journal and how long does it ususally take to get results from a clinical P3 trial published in a scientific journal?

So, when did NWBO start to work on the journal? Probably NWBO have already been doing the groundwork on the journal by data lock, but let us settle for, that the peer reviewing work with statisticians, will be started, when statisticians get back with summaries. TLD could be done fairly quick or it could take longer, if there needed to be ping-pong between statisticians and NWBOs "people". Added to that, the circumstances of Covid, which NWBO mentioned in its Q10 report released in time for ASM 2021.

As also previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and process of analyzing the Phase III trial results, especially with the successive waves of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned for COVID, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses, continue to have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays

But we know, that Kristyn Power got offered a job, and that she accepted leaving her manager job at Deloitte for a manager job in Toronto for NWBO. We know she was hired April 1st.

I strongly assume, that no one in their right mind, accepts a job, unknowingly if they have that job in 6 months because the phase 3 trial regarding the vaccine ones job revolved around, has failed. So I assume, that KP got the knowledge before she agreed, that is, March 2021 lates, which means NWBO was unblinded February/March latest.

Doing a little bit of math, one can calculate, that NWBO thus has been working on the scientific journal about 290-320 days.

If one take a look at the statistics of time spent, for getting a scientific journal ready for publication after being unblinded, then we have these studies

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145729/

A study we can also find here:

https://jamanetwork.com/journals/jamaoncology/fullarticle/2678095

Of the 100 press releases in our sample, 70 (70%) reported positive results, but only 31 (31%) included the magnitude of study findings. Through the end of follow-up, 99 (99%) of press releases had an associated peer-reviewed publication, complete data posting to ClinicalTrials.gov, or both, with a median time to reporting of 300 days (95% CI, 263-348 days). Positive findings were reported more quickly than negative ones (median of 272; 95% CI, 211-318 days vs 407; 95% CI, 298-705 days; log-rank P?<?.001).

Conclusions and Relevance
Even for the most pressing study findings, median publication delays approach 1 year. As publication delays hinder research progress and advancements in clinical care, policies that enable early preprint release or public posting of completed data analysis should be pursued.


A median for positive findings at 272 days, which correlates very well with the current used time spent by NWBO, not least considering the Covid impacts that most have occured, small or large.

The predictions at autumn 2020 were by and large influenced by NWBO having stated BEFORE data lock, that TLD would be coming quick. But NWBO chose another strategy when data lock finally hit and opted for getting the top line data supported by peer reviewed scientific non-refutable facts.

Contrary to somes belief, that has NOT been to the avail of patients having to wait longer for treatment, nor has it delayed NWBO progressing on exact all the other parameters that they would've expected to deal with after a quick TLD.

NWBO would've had to get a scientific journal done, that could explain the data anyway.

The would've had to build out Sawston and get manufactoring and production in place.

They would've had to get Sawston MHRA certified.

They would've had to start the approval process of DCVax-L.

They would've had to get Advent Bio in place to support the production with hirings.

All of the above, NWBO has luckily been progressing on all these parts during data lock, so all in all, the so called "delay", has not been a delay at all, but in the minds of those who - somehow strangely - believes, that when positive TLD has been proclaimed, a patient can inquire for his/hers personal vaccine the very next day.

That is not how the piano plays though.

There's not so much too it.

But of course if the prosecution opts for panic, then the prosecution should do that.